Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic and Pharmacodynamic Profile of BIA 3-202

• Register: ClinicalTrials.gov
• Last refreshed on: 17 May 2016
• Main ID: NCT02763800
• Date of registration: 04/05/2016
• Prospective Registration: No
• Primary sponsor: Bial - Portela C S.A.
• Public title: Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic and Pharmacodynamic Profile of BIA 3-202
• Scientific title: Double-Blind, Randomised, Placebo-Controlled, Rising Multiple Dose Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic and Pharmacodynamic Profile of BIA 3-202, in Young Healthy Volunteers
• Date of first enrolment: September 2000
• Target sample size: 33
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02763800
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United Kingdom

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adult males aged 18-35 years, with a body mass index (BMI) of 19-28 kg/m2.

- Subjects who were healthy as determined by pre-study medical history, physical
examination and 12-lead ECG.

- Subjects who had clinical laboratory tests acceptable to the investigator.

- Subjects who were negative for HbsAg, anti-HCV and HIV I and II tests at screening.

- Subjects who were negative for drugs of abuse and alcohol tests at screening and
admission.

- Subjects who were non-smokers or who smoked less than 10 cigarettes or equivalent per
day.

- Subjects who were able and willing to give written informed consent.

Exclusion Criteria:

- Subjects who did not conform to the above inclusion criteria.

- Subjects who had a clinically relevant history or presence of respiratory,
gastrointestinal, renal, hepatic, haematological, lymphatic, neurological,
cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological,
dermatological, connective tissue diseases or disorders.

- Subjects who had a clinically relevant surgical history.

- Subjects who had a clinically relevant family history.

- Subjects who had a history of relevant atopy.

- Subjects who had a history of relevant drug hypersensitivity.

- Subjects who had a history of alcoholism.

- Subjects who had a history of drug abuse.

- Subjects who consumed more than 28 units of alcohol a week.

- Subjects who had a significant infection or known inflammatory process on screening
and/or admission.

- Subjects who had acute gastrointestinal symptoms at the time of screening and/or
admission (e.g. nausea, vomiting, diarrhoea, heartburn).

- Subjects who had an acute infection such as influenza at the time of screening and/or
admission.

- Subjects who had used prescription drugs within 4 weeks of first dosing.

- Subjects who had used over the counter medication, excluding routine vitamins but
including mega dose vitamin therapy, within one week of first dosing.

- Subjects who had used any investigational drug and/or participated in any clinical
trial within 3 months of their first admission to this study.

- Subjects who had previously received BIA 3-202.

- Subjects who had donated and/or received any blood or blood products within 3 months
prior to screening.

- Subjects who were vegetarians, vegans and/or had medical dietary restrictions.

- Subjects who could not communicate reliably with the investigator.

- Subjects who were unlikely to co-operate with the requirements of the study.

- Subjects who were unwilling or unable to give written informed consent.



Age minimum: 18 Years
Age maximum: 35 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: Placebo

Drug: BIA 3-202

Primary Outcome(s)

Area under the plasma concentration time curve extrapolated to infinity (AUC0-8) - D9 [Time Frame: Day 9]

Area under the plasma concentration time curve to last measurable time point (AUC0-t) - D9 [Time Frame: Day 9]

Area under the plasma concentration time curve extrapolated to infinity (AUC0-8) - D1 [Time Frame: Day 1]

Area under the plasma concentration time curve to last measurable time point (AUC0-t) - D1 [Time Frame: Day 1]

Maximum observed plasma concentration (Cmax) - D1 [Time Frame: Day 1]

Maximum observed plasma concentration (Cmax) - D9 [Time Frame: Day 9]

Time of maximum observed concentration (tmax) - D1 [Time Frame: Day 1]

Time of maximum observed concentration (tmax) - D9 [Time Frame: Day 9]

Secondary ID(s)

BIA-3202-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors